Bausch Health Companies Inc. together with its gastroenterology enterprise, Salix Pharmaceuticals, Inc., has filed a lawsuit within the United States District Court in opposition to Amneal Pharmaceuticals.

According to a report by Pharmabiz, this lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) looking for approval to market a generic model of Xifaxan (rifaximin) 550 mg tablets.

The report reveals that Amneal asserts that sure patents listed within the FDA’s Orange Book for Xifaxan are “unenforceable, invalid, and/or not infringed by Amneal’s ANDA product.” This motion formally initiates the litigation course of below the Hatch-Waxman Act and triggers a 30-month keep of any potential FDA approval for Amneal’s ANDA.

“Bausch Health remains confident in its Xifaxan intellectual property and we will continue to defend our Xifaxan franchise for the benefit of patients,” Thomas J. Appio, CEO, Bausch Health stated as quoted by Pharmabiz. “As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies.”

Bausch Health has beforehand obtained Paragraph IV Certifications for Xifaxan (rifaximin) 550 mg tablets from Teva Pharmaceuticals, Sandoz Inc., Sun Pharmaceuticals and Norwich Pharmaceuticals. The firm has since settled the issues with Teva, Sandoz and Sun in September 2018, May 2020 and September 2020, respectively, whereas litigation with Norwich stays ongoing.

Xifaxan (rifaximin) 550 mg tablets are indicated for the discount in danger of overt hepatic encephalopathy (HE) recurrence in adults and the therapy of irritable bowel syndrome with diarrhoea (IBS-D) in adults.

Salix Pharmaceuticals is without doubt one of the largest specialty pharmaceutical corporations on this planet dedicated to the prevention and therapy of gastrointestinal illnesses.

Bausch Health Companies Inc. is a worldwide diversified pharmaceutical firm enriching lives by way of our relentless drive to ship higher health care outcomes. The firm develop, manufacture and market a variety of merchandise primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic units, worldwide prescription drugs and eye well being, by way of its controlling curiosity in Bausch + Lomb.